Six Month Pooled Outcomes From Randomized and Crossover Patients
Following Renal Denervation Presented at the 22nd
Annual Scientific Meeting of the European Society of Hypertension
Confirm Previous Symplicity Clinical Trial Findings
MINNEAPOLIS & LONDON, Apr 27, 2012 (BUSINESS WIRE) --Medtronic, Inc., (NYSE: MDT), announced today six month pooled outcomes
from randomized and crossover patients in the Symplicity HTN-2 clinical
trial following renal denervation with the Symplicity(TM) renal denervation
system showing significant, sustained blood pressure reduction in
patients with treatment-resistant hypertension. These data presented
today at the European Society of Hypertension annual meeting showed
patients (n=84) who received renal denervation treatment with Symplicity
experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001)
at six months following treatment compared with baseline. No evidence of
renal impairment was observed and renal function measures remained
unchanged.
This pooled analysis included change in blood pressure at six months for
all patients randomized to receive renal denervation with Symplicity at
baseline (n=49), as well as patients in the control group (n=35) who met
entry criteria and crossed over to the treatment group following
assessment of the initial six month primary endpoint.
"The Symplicity clinical program is the longest and largest clinical
program of its kind evaluating renal denervation in resistant
hypertension," said Markus Schlaich, M.D., associate professor, head,
Hypertension & Kidney Disease, Baker IDI Heart and Diabetes
Institute in Melbourne, Australia. "This largest pooled analysis of
controlled trial data at six months adds to the growing body of clinical
evidence about the safety, effectiveness and sustainability of blood
pressure reductions achieved with renal denervation."
Renal denervation therapy is a minimally invasive, catheter-based
procedure that modulates the output of nerves that lie within the renal
artery wall and lead into and out of the kidneys. These nerves are part
of the sympathetic nervous system, which affects the major organs that
are responsible for regulating blood pressure: the brain, the heart, the
kidneys and the blood vessels.
The Symplicity(TM) system's catheter and proprietary generator and
algorithms were carefully and specifically developed through years of
clinical experience to enhance the safety and effectiveness of the renal
denervation procedure. The Symplicity renal denervation system has
been successfully used for nearly five years to treat more than 4,000
patients with treatment-resistant hypertension worldwide.
"New treatment guidance issued by the European Society of Hypertension
on the use of renal denervation to treat resistant hypertension supports
the use of technology that has demonstrated enduring safety and
effectiveness safety in clinical studies," said Sean Salmon, Senior Vice
President and President, Coronary & Renal Denervation, Medtronic. "We
believe our Symplicity technology specifically designed for this
procedure, coupled with encouraging results from the Symplicity clinical
trials with three years of follow-up fall within these renal denervation
treatment guidelines."
Six-Month Pooled Outcome Data from the Symplicity
HTN-2 Study
The Symplicity HTN-2 triali is an international,
multi-center, prospective, randomized, controlled study of the safety
and effectiveness of renal denervation in patients with
treatment-resistant hypertension. One hundred-six (106) patients were
enrolled from 24 investigational sites. At baseline, the randomized
treatment and control patients had similar high blood pressures: 178/97
mm Hg and 178/98 mm Hg, respectively, despite both receiving an average
daily regimen of five antihypertensive medications. Patients in the
control arm of the study were offered renal denervation following
assessment of the trial's primary endpoint at six months following
randomization. Pre-randomization, all patients in the study had an
office-based systolic blood pressure greater-than or equal to 160 mm Hg despite adherence to at
least three antihypertensive medications given at optimal dosage. Mean
change in systolic and diastolic blood pressure was -28/-10 mg Hg (n=84)
from baseline (p<0.001) to six months post-treatment. Renal function
measures were unchanged (eGFR: 82.1±20.2 vs. 80.5±18.9mL/min/1.73m2;
p=NS). There was one right artery dissection in a crossover patient,
which occurred while injecting contrast during angiography. No other
serious procedure-related adverse events occurred.
ABOUT TREATMENT-RESISTANT HYPERTENSION
Treatment-resistant hypertension, defined as persistently high blood
pressure despite three or more anti-hypertensive medications of
different types including a diuretic, puts approximately 120 million
people worldwide at risk of premature death from kidney disease and
cardiovascular events such as stroke, heart attack and heart failure.
Research suggests that nearly one third of treated hypertensive
individuals are considered resistant to treatment.ii
Additionally, these patients have a three-fold increase in risk of
cardiovascular events compared to individuals with controlled high blood
pressure.iii
ABOUT THE SYMPLICITY(TM) RENAL DENERVATION
SYSTEM
The Symplicity(TM) renal denervation system was launched
commercially in April 2010 and is currently available in parts of
Europe, Asia, Africa, Australia and the Americas. The Symplicity renal
denervation system is not approved by the U.S. Food and Drug
Administration (FDA) for commercial distribution in the United States.
The Symplicity renal denervation system consists of a flexible catheter
and proprietary generator. In an endovascular procedure, similar to an
angioplasty, the physician inserts the small, flexible Symplicity(TM)
catheter into the femoral artery in the upper thigh and threads it into
the renal artery. Once the catheter tip is in place within the renal
artery, the Symplicity(TM) generator is activated to deliver a controlled,
low-power radio-frequency (RF) energy routine according to a proprietary
algorithm, or pattern, aiming to deactivate the surrounding renal
nerves. This, in turn, reduces hyper-activation of the sympathetic
nervous system, which is an established contributor to chronic
hypertension. The procedure does not involve a permanent implant.
The FDA granted Medtronic approval for the protocol for SYMPLICITY
HTN-3, the company's U.S. clinical trial of the Symplicity renal
denervation system for treatment resistant hypertension in August 2011.
SYMPLICITY HTN-3 is a randomized controlled trial designed to evaluate
the safety and effectiveness of renal denervation with the Symplicity
renal denervation system in patients with treatment-resistant
hypertension. The study will include approximately 530
treatment-resistant hypertension patients across up to 90 U.S. medical
centers. More information about HTN-3 can be found at www.symplifybptrial.com.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of
cardiovascular disease and cardiac arrhythmias.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology
- alleviating pain, restoring health and extending life for millions of
people around the world.
Any forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic's periodic reports on file with the
Securities and Exchange Commission. Actual results may differ materially
from anticipated results.
i Symplicity HTN-2 Investigators. "Renal sympathetic
denervation in patients with treatment-resistant hypertension (The
Symplicity HTN-2 Trial): a randomized, controlled trial." The Lancet
(2010) 376: 1093-1909.
ii Egan, Brent M., et al. "Uncontrolled and Apparent
Treatment Resistant Hypertension in the United States, 1988-2008." Circulation
124. 9 (2011): 1046-1058.
iii Doumas, Michael, et al. "Benefits from Treatment and
Control of Patients with Resistant Hypertension." International
Journal of Hypertension 2011 (2011) Article ID 318549, 8 pages,
2011. doi:10.4061/2011/318549.
Symplicity is a trademark of Medtronic Inc. and is registered in one or
more countries of the world.
SOURCE: Medtronic, Inc.
Medtronic, Inc.
Wendy Dougherty, 763-381-1204
Public Relations
or
Jeff
Warren, 763-505-2696
Investor Relations
